Clinical trial · Interventional
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
NCT07678593CI-TRIAL-00117583not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors Cancer | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| RAS Mutation | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| GFH276 | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: GFH276 + Cetuximab
- description
- GFH276 once daily; cetuximab 500 mg/m² intravenous infusion every 2 weeks.
- interventionNames
- Drug: GFH276
- Drug: Cetuximab
- type
- EXPERIMENTAL
- label
- Arm B: GFH276 + AG
- description
- GFH276 once daily; nab-paclitaxel 125 mg/m² + gemcitabine 1000 mg/m² (AG regimen); 4-week cycle (D1, D8, D15) or 3-week cycle (D1, D8) in China
- interventionNames
- Drug: GFH276
- Drug: Nab paclitaxel
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Arm C: GFH276 + mFOLFIRINOX
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification 3. At least one measurable lesion according to RECIST v1.1 4. ECOG performance status 0 or 1 5. Life expectancy \> 3 months 6. Adequate organ function 7. Willing to provide written informed consent 8. Fertile participants must use effective contraception Exclusion Criteria: 1. Other active malignancy within 3 years 2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor 3. History of active clinically significant cardiovascular dysfunction 4. For participants with known concomitant second oncodriver for PDAC or for solid tumors. 5. With active infection (HIV, HBV, HCV, syphilis) 6. The presence of clinical or radiological evidence of intestinal obstruction. 7. Prior anticancer therapy within 28 days or 5 half-lives 8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months 9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures. 10. History of central nervous system (CNS)disease 11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment. 12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
References
Publications (0)
Data not yet available
No reference posted for this study.